Composite RestorationsNCT07174271
Evaluation of Patient Satisfaction Following Anterior Composite Restorations: Immediate and One-Week Comparisons
An observational study of Composite Restorations, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary The goal of this observational study is to learn about patient-centered evaluations of anterior composite restorations performed under rubber dam isolation in adults treated at a university dental clinic. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Composite Restorations
- What is being tested?
- Patient satisfaction survey upon completion of anterior composite restorations and during follow-up sessions
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2023to 21 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will consist of systemically healthy individuals aged 18 to 35 years who are capable of understanding and providing informed consent. Eligible participants must present with clinically healthy gingiva and periodontium, no bleeding or plaque accumulation, and vital maxillary incisors and canines (teeth 11, 12, 13, 21, 22, 23) without signs of irreversible pulpitis. Individuals with systemic diseases, disabilities, poor oral hygiene compliance, contraindications to rubber dam placement (e.g., asthma, mouth breathing, partially erupted or malposed teeth, latex allergy), or with signs of periapical or pulpal pathology will be excluded.
Who may be able to join
- 18-35 years old
- Sufficient cognitive ability to understand the consent process
- Clinically healthy gingiva and periodontium
- No bleeding or plaque accumulation
- Vital upper incisors and canines without signs of irreversible pulpitis (11-12-13-21-22-23)
Who cannot join
- Any disability (mental health conditions, mental disabilities and physical disabilities)
- Systemic diseases or serious medical risks (cardiovascular disorders, diabetes, hypertension, epilepsy)
- Compliance problems, inability to maintain hygiene after treatment
- Patients contraindicated for rubber dam placement (patient with asthma diagnosis, mouth breathing, partially erupted teeth, excessively malposed teeth and latex allergy)
- Signs of periapical pathology or pulpal posterior or anterior pathology
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry
Istanbul, Istanbul Asya Kitasi, 34846
About this study
Brief Summary
The goal of this observational study is to learn about patient-centered evaluations of anterior composite restorations performed under rubber dam isolation in adults treated at a university dental clinic. The main questions it aims to answer are:
Read more
How do patients rate their restorations immediately after treatment?
Do patient evaluations change one week after treatment compared to immediate assessment?
The study group consisted of vital maxillary central and lateral incisors and canines. Individuals requiring partial diastema or full-coverage restorations in one to six anterior teeth were included in the study. All restorative procedures were performed under rubber dam isolation in accordance with standard protocols. Restorations were immediately evaluated by patients after treatment and reassessed during a one-week follow-up session.
Evaluations were conducted using questions based on Fédération Dentaire Internationale (FDI) criteria. However, since the FDI criteria were primarily designed for dentists, it was not possible for patients to score the restorations according to the classic model. Instead, patient assessment was achieved by asking them to give a score between 0 and 10 for each category.
A total of 50 patients were included in the study, and the number of teeth evaluated varied depending on the number of anterior restorations performed on each patient.
In the questionnaire, patients were asked a total of five questions regarding the esthetic anatomical form , color harmony and translucency , surface smoothness, adjacent mucosal conditions , and post-operative sensitivity.
Read the detailed description
In Marmara University Faculty of Dentistry Restorative Dentistry Clinic (hangi üniversite hangi klinik), a questionnaire was conducted. The study group vital maxillary central incisors, lateral incisors, and canines . The participants in the study comprised individuals who were in need of partial diastema or full-veneer restorations on one to six teeth in the anterior region. All restorative procedures were performed under rubber dam isolation in accordance with standard protocols. The restorations were evaluated by patients immediately following treatment and then re-evaluated during a one-week follow-up session. The restorations were evaluated by patients through questions prepared with reference to the FDI (Fédération Dentaire Internationale) Since the FDI criteria is designed for dental professionals, the patients were not able to score the restorations in a classical pattern. The patients scored the restorations giving a number from 0 to 10 for each category. In an effort to reduce variability and ensure standardisation, all restorative procedures were performed in the same clinical setting by a single experienced operator. In order to standardise lighting conditions, all evaluations were conducted at the same time of day and within the same clinical room. During the evaluation process, patients were provided with a large mirror, which facilitated a comprehensive assessment of their entire smile, as opposed to a small hand mirror that might not have allowed for such a thorough examination. The questionnaire study was started after the approval of the restoration completion by the department supervisors. Patients were not called for the questionnaire study outside of routine controls, evaluations were made immediately after the restorations are completed and at 1-week control sessions. The number of patients to be included in the study was determined by power analysis. A total of 50 patients are planned to be included in our study. The number of teeth to be evaluated will vary depending on the number of anterior restorations in total patients.
Inclusion criteria comprised patients aged 18 to 35 years with sufficient cognitive ability to comprehend and provide informed consent, clinically healthy gingiva and periodontium without bleeding or plaque accumulation, and vital maxillary incisors and canines free from clinical signs of irreversible pulpitis. Eligible participants presented with one to six teeth in the anterior maxillary region requiring either diastema closure or full veneer restorations, and all restorative procedures were performed under rubber dam isolation. Exclusion criteria included the presence of mental, cognitive, or physical disabilities; systemic diseases or serious medical risks such as cardiovascular disorders, diabetes mellitus, hypertension, or epilepsy; poor compliance or inability to maintain oral hygiene after treatment; and contraindications for rubber dam placement, including asthma, predominant mouth breathing, partially erupted or severely malposed teeth, or latex allergy. Patients with clinical or radiographic evidence of periapical pathology or pulpal pathology affecting either anterior or posterior teeth were also excluded.
In the questionnaire, a total of 5 questions were asked to the patients about esthetic anatomical form , color harmony and translucency, smoothness of the surface, adjacent mucosa, post-operative sensitivity and tooth vitality.
- Conditions
- Composite Restorations
- Being tested
- Patient satisfaction survey upon completion of anterior composite restorations and during follow-up sessions
- Keywords
- composite restorations, Patient satisfaction, control sessions
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient satisfaction survey upon completion of anterior composite restorations and during follow-up sessionsOther
This study focuses on evaluating patient satisfaction with anterior composite restorations immediately after treatment and during subsequent follow-up visits. A structured questionnaire, based on modifications of the Fédération Dentaire Internationale (FDI) criteria, was administered to patients. Since the original FDI criteria were primarily designed for dentist-based evaluation, the questions were adapted into a patient-friendly format.
Participants were asked to rate restorations across multiple domains, including esthetic anatomical form, color harmony and translucency, surface smoothness, the condition of the adjacent mucosa, and post-operative sensitivity and tooth vitality. Each parameter was scored on a numerical scale ranging from 0 to 10, allowing patients to express their subjective perception of treatment outcomes.
By collecting these patient-reported outcomes both immediately after the procedure and during follow-up sessions, the study aims to provide a comprehensive under
| Study group | Role | What they receive |
|---|---|---|
| Anterior Composite Restoration Group | Anterior Composite Restoration Group - Single cohort of healthy participants receiving direct anterior composite restorations on maxillary central/lateral incisors or canines. Eligibility included vital anterior teeth with healthy periodontium and an esthetic need (e.g., partial diastema closure or full-coverage/esthetic restoration) in 1-6 teeth. Procedures were performed under rubber-dam isolation with a standardized protocol in the same clinic. Patient-reported outcomes were collected immediately post-treatment and at 1-week using a patient-adapted, FDI-based questionnaire (A4, A3, A1, C15, C11; 0-10 scale). Receives: Other: Patient satisfaction survey upon completion of anterior composite restorations and during follow-up sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Satisfaction Scores for Anterior Composite Restorations from Post-Treatment to 1-Week Follow-up
Patient satisfaction with anterior composite restorations was assessed immediately after treatment and at a 1-week follow-up visit. Evaluations were performed using a patient-adapted questionnaire based on the Fédération Dentaire Internationale (FDI) criteria. Because FDI criteria were originally designed for dentist-based assessment, the questions were simplified into a 0-10 numeric rating scale for patients.
The questionnaire included five domains:
Esthetic Anatomical Form Scale: 0-10(0 = very poor anatomical form, 10 = excellent anatomical form) Color Harmony and Translucency Scale: 0-10(0 = severe mismatch in color/translucency, 10 = perfect match with natural tooth) Surface Smoothnes Scale: 0-10(0 = very rough surface, 10 = perfectly smooth surface) Adjacent mucosal condition, Scale: 0-10(0 = severe inflammation, bleeding or pathology, 10 = healthy adjacent mucosa with no sign) Post-operative Sensitivity and Tooth Vitality Scale: 0-10 (0 = no sensitivity with preserved vitality)
Measured: Immediately after treatment and at 1-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start2 Jun 2023
- Primary completion22 Dec 2023
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Composite RestorationsStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174271
- Sponsor's protocol ID
- 09.2023.816
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data obtained without working will be shared if requested.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction Following Anterior Composite Restorations: Immediate and One-Week Comparisons
- ClinicalTrials.gov ID
- NCT07174271
- Acronym / sponsor ID
- 09.2023.816
- Conditions
- Composite Restorations
- Keywords
- composite restorations, Patient satisfaction, control sessions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Summary
The goal of this observational study is to learn about patient-centered evaluations of anterior composite restorations performed under rubber dam isolation in adults treated at a university dental clinic. The main questions it aims to answer are:
How do patients rate their restorations immediately after treatment?
Do patient evaluations change one week after treatment compared to immediate assessment?
The study group consisted of vital maxillary central and lateral incisors and canines. Individuals requiring partial diastema or full-coverage restorations in one to six anterior teeth were included in the study. All restorative procedures were performed under rubber dam isolation in accordance with standard protocols. Restorations were immediately evaluated by patients after treatment and reassessed during a one-week follow-up session.
Evaluations were conducted using questions based on Fédération Dentaire Internationale (FDI) criteria. However, since the FDI criteria were primarily designed for dentists, it was not possible for patients to score the restorations according to the classic model. Instead, patient assessment was achieved by asking them to give a score between 0 and 10 for each category.
A total of 50 patients were included in the study, and the number of teeth evaluated varied depending on the number of anterior restorations performed on each patient.
In the questionnaire, patients were asked a total of five questions regarding the esthetic anatomical form , color harmony and translucency , surface smoothness, adjacent mucosal conditions , and post-operative sensitivity.
Detailed description
In Marmara University Faculty of Dentistry Restorative Dentistry Clinic (hangi üniversite hangi klinik), a questionnaire was conducted. The study group vital maxillary central incisors, lateral incisors, and canines . The participants in the study comprised individuals who were in need of partial diastema or full-veneer restorations on one to six teeth in the anterior region. All restorative procedures were performed under rubber dam isolation in accordance with standard protocols. The restorations were evaluated by patients immediately following treatment and then re-evaluated during a one-week follow-up session. The restorations were evaluated by patients through questions prepared with reference to the FDI (Fédération Dentaire Internationale) Since the FDI criteria is designed for dental professionals, the patients were not able to score the restorations in a classical pattern. The patients scored the restorations giving a number from 0 to 10 for each category. In an effort to reduce variability and ensure standardisation, all restorative procedures were performed in the same clinical setting by a single experienced operator. In order to standardise lighting conditions, all evaluations were conducted at the same time of day and within the same clinical room. During the evaluation process, patients were provided with a large mirror, which facilitated a comprehensive assessment of their entire smile, as opposed to a small hand mirror that might not have allowed for such a thorough examination. The questionnaire study was started after the approval of the restoration completion by the department supervisors. Patients were not called for the questionnaire study outside of routine controls, evaluations were made immediately after the restorations are completed and at 1-week control sessions. The number of patients to be included in the study was determined by power analysis. A total of 50 patients are planned to be included in our study. The number of teeth to be evaluated will vary depending on the number of anterior restorations in total patients.
Inclusion criteria comprised patients aged 18 to 35 years with sufficient cognitive ability to comprehend and provide informed consent, clinically healthy gingiva and periodontium without bleeding or plaque accumulation, and vital maxillary incisors and canines free from clinical signs of irreversible pulpitis. Eligible participants presented with one to six teeth in the anterior maxillary region requiring either diastema closure or full veneer restorations, and all restorative procedures were performed under rubber dam isolation. Exclusion criteria included the presence of mental, cognitive, or physical disabilities; systemic diseases or serious medical risks such as cardiovascular disorders, diabetes mellitus, hypertension, or epilepsy; poor compliance or inability to maintain oral hygiene after treatment; and contraindications for rubber dam placement, including asthma, predominant mouth breathing, partially erupted or severely malposed teeth, or latex allergy. Patients with clinical or radiographic evidence of periapical pathology or pulpal pathology affecting either anterior or posterior teeth were also excluded.
In the questionnaire, a total of 5 questions were asked to the patients about esthetic anatomical form , color harmony and translucency, smoothness of the surface, adjacent mucosa, post-operative sensitivity and tooth vitality.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior Composite Restoration Group | – | Other: Patient satisfaction survey upon completion of anterior composite restorations and during follow-up sessionsAnterior Composite Restoration Group - Single cohort of healthy participants receiving direct anterior composite restorations on maxillary central/lateral incisors or canines. Eligibility included vital anterior teeth with healthy periodontium and an esthetic need (e.g., partial diastema closure or full-coverage/esthetic restoration) in 1-6 teeth. Procedures were performed under rubber-dam isolation with a standardized protocol in the same clinic. Patient-reported outcomes were collected immediately post-treatment and at 1-week using a patient-adapted, FDI-based questionnaire (A4, A3, A1, C15, C11; 0-10 scale). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will consist of systemically healthy individuals aged 18 to 35 years who are capable of understanding and providing informed consent. Eligible participants must present with clinically healthy gingiva and periodontium, no bleeding or plaque accumulation, and vital maxillary incisors and canines (teeth 11, 12, 13, 21, 22, 23) without signs of irreversible pulpitis. Individuals with systemic diseases, disabilities, poor oral hygiene compliance, contraindications to rubber dam placement (e.g., asthma, mouth breathing, partially erupted or malposed teeth, latex allergy), or with signs of periapical or pulpal pathology will be excluded.
Key inclusion criteria (5 listed)
- 18-35 years old
- Sufficient cognitive ability to understand the consent process
- Clinically healthy gingiva and periodontium
- No bleeding or plaque accumulation
- Vital upper incisors and canines without signs of irreversible pulpitis (11-12-13-21-22-23)
Key exclusion criteria (5 listed)
- Any disability (mental health conditions, mental disabilities and physical disabilities)
- Systemic diseases or serious medical risks (cardiovascular disorders, diabetes, hypertension, epilepsy)
- Compliance problems, inability to maintain hygiene after treatment
- Patients contraindicated for rubber dam placement (patient with asthma diagnosis, mouth breathing, partially erupted teeth, excessively malposed teeth and latex allergy)
- Signs of periapical pathology or pulpal posterior or anterior pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient satisfaction survey upon completion of anterior composite restorations and during follow-up sessionsThis study focuses on evaluating patient satisfaction with anterior composite restorations immediately after treatment and during subsequent follow-up visits. A structured questionnaire, based on modifications of the Fédération Dentaire Internationale (FDI) criteria, was administered to patients. Since the original FDI criteria were primarily designed for dentist-based evaluation, the questions were adapted into a patient-friendly format. Participants were asked to rate restorations across multiple domains, including esthetic anatomical form, color harmony and translucency, surface smoothness, the condition of the adjacent mucosa, and post-operative sensitivity and tooth vitality. Each parameter was scored on a numerical scale ranging from 0 to 10, allowing patients to express their subjective perception of treatment outcomes. By collecting these patient-reported outcomes both immediately after the procedure and during follow-up sessions, the study aims to provide a comprehensive under | Other | Anterior Composite Restoration Group |
Primary outcome
Change in Patient Satisfaction Scores for Anterior Composite Restorations from Post-Treatment to 1-Week Follow-up
Time frame: Immediately after treatment and at 1-week follow-up
Patient satisfaction with anterior composite restorations was assessed immediately after treatment and at a 1-week follow-up visit. Evaluations were performed using a patient-adapted questionnaire based on the Fédération Dentaire Internationale (FDI) criteria. Because FDI criteria were originally designed for dentist-based assessment, the questions were simplified into a 0-10 numeric rating scale for patients. The questionnaire included five domains: Esthetic Anatomical Form Scale: 0-10(0 = very poor anatomical form, 10 = excellent anatomical form) Color Harmony and Translucency Scale: 0-10(0 = severe mismatch in color/translucency, 10 = perfect match with natural tooth) Surface Smoothnes Scale: 0-10(0 = very rough surface, 10 = perfectly smooth surface) Adjacent mucosal condition, Scale: 0-10(0 = severe inflammation, bleeding or pathology, 10 = healthy adjacent mucosa with no sign) Post-operative Sensitivity and Tooth Vitality Scale: 0-10 (0 = no sensitivity with preserved vitality)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Yes. All data obtained without working will be shared if requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Composite Restorations, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Satisfaction Scores for Anterior Composite Restorations from Post-Treatment to 1-Week Follow-up (time frame: Immediately after treatment and at 1-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.